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Model Number BI-PAP FOCUS SYSTEM, USA |
Device Problem
Defective Alarm (1014)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/30/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Submission date: 28sep2021.
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Event Description
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The customer reported diagnostic error "primary alarm failed".Just back from bench repair.Patient or user involvement information is unknown but has been requested.No patient or user harm was reported.The field service engineer (fse) confirmed on bootup the unit gave "primary alarm failed"."post primary audible failed" and " motor speaker: fail¿ were also found in the diagnostic in event logs.The motor controller speaker did not make any sound.The fse ordered a motor controller speaker to resolve the issue.The fse replaced the speaker assembly to resolve the issue.The unit was tested, and it was returned to service.
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Manufacturer Narrative
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The device was not in use on a patient.No patient or user harm was reported.
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Search Alerts/Recalls
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